Group 1 - The core product, TY-9591, has received acceptance for its new drug application (NDA) by the National Medical Products Administration, targeting non-small cell lung cancer brain metastases, and is the first next-generation EGFR-TKI inhibitor [1] - The estimated peak annual sales for TY-9591 in China is projected to exceed 5 billion yuan, indicating significant market potential for brain metastases and L858R mutation [1] - The Hong Kong Stock Exchange has approved the full circulation arrangement for the company's H-shares, involving the conversion of 4.608 million non-listed shares, which will enhance share liquidity [1] Group 2 - The stock price has shown volatility, closing at 12.80 HKD on February 13, 2026, a slight decrease of 0.78% from the previous close of 12.86 HKD, with a trading range of 7.52% [2] - The total trading volume from February 9 to 13, 2026, was approximately 1.038 billion HKD, with a narrowing turnover rate of 0.30% [2] - Technical indicators show improvement in short-term momentum, with the MACD histogram turning positive at 0.077 and the KDJ indicator's J line rising to 50.903 [2] Group 3 - The company's mid-2025 performance report indicates improved operational efficiency, with R&D costs reduced by 35.6% year-on-year to 88.758 million yuan, and losses narrowed by 48.79% to 112 million yuan [3] - The current revenue primarily relies on a licensing agreement with Livzon Pharmaceutical, and a commercialization team has been preliminarily established to prepare for product launches [3]

Group 1 - The company, Tongyuan Kang Pharmaceutical-B (02410), has applied to the Stock Exchange Listing Committee for approval to convert 4.608 million non-listed shares held by one shareholder into 4.608 million H shares for listing and trading [1] - The Stock Exchange granted the listing approval on February 11, 2026 [1]

Core Viewpoint - The company, ZhiYuanKang Pharmaceutical-B (02410), has applied to the Hong Kong Stock Exchange for approval to list and trade 4.608 million H-shares converted from non-listed shares held by a shareholder, with approval granted on February 11, 2026 [1] Group 1 - The company has submitted an application to the listing committee of the Hong Kong Stock Exchange [1] - The application involves the conversion of 4.608 million non-listed shares into H-shares [1] - The listing approval was granted by the Hong Kong Stock Exchange on February 11, 2026 [1]

香港交易及結算所有限公司及香港聯合交易所有限公司對本公告的內容概不負責，對其準確性 或完整性亦不發表任何意見，並明確表示概不就因本公告全部或任何部分內容而產生或因倚賴 該等內容而引致的任何損失承擔任何責任。 本公告乃由浙江同源康醫藥股份有限公司（「本公司」）根據香港聯合交易所有限公 司（「聯交所」）證券上市規則（「上市規則」）第13.09(2)(a)條及香港法例第571章證 券及期貨條例第XIVA部項下內幕消息條文（「內幕消息條文」）（定義見上市規則） 作出。 茲提述(i)本公司日期為2025年6月6日的公告，內容有關本公司申請H股全流通； 及(ii)本公司日期為2026年1月23日的公告，內容有關中國證監會發出關於本公司 申請H股全流通的備案通知書（統稱「該等公告」）。除文義另有所指外，本公告所 用詞彙與該等公告所界定者具有相同涵義。 聯交所授出上市批准 本公司董事會欣然宣佈，本公司已向聯交所上市委員會申請批准本公司根據轉換 本公司1名股東持有的4,608,000股非上市股份（「轉換」）轉換的4,608,000股H股 （「經轉換H股」）上市（「上市」）及買賣經轉換H股（「上市批准」）。本公司欣然宣 佈，聯交 ...

Core Viewpoint - Tongyuan Kang Pharmaceutical has achieved a significant milestone with the acceptance of its New Drug Application (NDA) for TY-9591, a novel drug targeting brain metastases in non-small cell lung cancer (NSCLC) by the National Medical Products Administration (NMPA) of China [1][2] Group 1: Product Development and Market Position - TY-9591 is the first next-generation EGFR-TKI inhibitor specifically for lung cancer brain metastases, attracting considerable market attention due to its differentiated advantages [1][2] - The drug is a deuterated version of the already marketed drug Osimertinib, designed to reduce toxic metabolites and enhance blood-brain barrier penetration with a high dosage of 160mg [2][3] - The NDA submission is based on a pivotal clinical study (ESAONA) involving over 50 research centers in China, aimed at evaluating the efficacy and safety of TY-9591 compared to Osimertinib [3] Group 2: Commercialization and Supply Chain - The company has proactively established a GMP production facility in Zhejiang, covering 39,000 square meters, to ensure rapid commercialization and stable product supply [4] - Initial commercialization will involve collaboration with leading CDMO company Kelaiying to facilitate quick market entry [4] Group 3: Market Potential and Financial Projections - The global sales peak for Osimertinib is projected to exceed $6 billion in 2024, with domestic sales surpassing 8 billion RMB, indicating a competitive landscape for TY-9591 [4] - The estimated annual sales peak for TY-9591 in the domestic market is projected to be no less than 3 billion RMB for brain metastases and 2 billion RMB for patients with EGFR L858R mutations, with a total potential exceeding 5 billion RMB [5] Group 4: Pipeline and Business Development - The company is focused on lung and breast cancer, with multiple products targeting CDK pathways to address HR+/HER2- breast cancer management [6] - Recent clinical research results in the CDK field were presented at the 2025 ESMO conference, showcasing the company's robust pipeline [6] - The company has entered into a licensing agreement for its self-developed product TY-2136b with a major pharmaceutical company in Greater China, while retaining rights in other regions [6] Group 5: Corporate Governance and Market Communication - Recent shareholding changes by the company's chairman, Wu Yusheng, were clarified as part of an employee incentive program, not personal divestment, addressing market misunderstandings [7] - The company plans to implement a share buyback program to incentivize and reward its mid-to-senior level R&D personnel and management [7]

Core Viewpoint - The announcement of the New Drug Application (NDA) acceptance for TY-9591, a new generation EGFR-TKI inhibitor targeting brain metastases from non-small cell lung cancer (NSCLC), marks a significant milestone for the company and the treatment landscape for lung cancer patients in China [1][3]. Group 1: Drug Development and Clinical Trials - The NDA for TY-9591 has been officially accepted by the National Medical Products Administration (NMPA) in China, making it the first new generation EGFR-TKI specifically for lung cancer brain metastases [1][3]. - The NDA submission is based on results from a pivotal clinical study (ESAONA) that evaluated the efficacy and safety of TY-9591 compared to Osimertinib in NSCLC patients with brain metastases [3][4]. - The interim analysis of the ESAONA study showed an intracranial objective response rate (iORR) of 92.8% for the TY-9591 group compared to 76.1% for the Osimertinib group, indicating a statistically significant difference [4]. Group 2: Company Strategy and Future Plans - The submission of the NDA for TY-9591 represents a critical milestone for the company, indicating its entry into the commercialization phase and its commitment to addressing unmet clinical needs in cancer treatment [6][8]. - The company plans to continue exploring combination therapies and further clinical research to meet the clinical demands of patients with advanced NSCLC [5][6]. - The company has developed over ten innovative products since its establishment in 2017, focusing on next-generation kinase inhibitors to fulfill unmet clinical needs in cancer treatment [8].

Core Viewpoint - Tongyuan Kang Pharmaceutical-B (02410) has announced that its New Drug Application (NDA) for the self-developed drug, Tyrosine-9591 (甲磺酸艾多替尼片), targeting brain metastases of non-small cell lung cancer (NSCLC), has been officially accepted by the National Medical Products Administration (NMPA) in China, marking it as the first next-generation EGFR-TKI inhibitor for lung cancer brain metastases [1][5]. Group 1: Drug Development and Clinical Trials - The NDA submission is based on a pivotal registration clinical study (ESAONA) conducted in China, which is a multi-center, randomized, open-label, positive-controlled trial aimed at evaluating the efficacy and safety of Tyrosine-9591 compared to Osimertinib in NSCLC patients with brain metastases [3]. - The mid-term analysis of the ESAONA study, presented at the WCLC2025 conference, showed an intracranial objective response rate (iORR) of 92.8% for the Tyrosine-9591 group compared to 76.1% for the Osimertinib group, indicating a statistically significant difference [4]. - Tyrosine-9591 is designed for first-line treatment of adult patients with locally advanced or metastatic NSCLC who have EGFR exon 19 deletions or L858R mutations and central nervous system (CNS) metastases [2]. Group 2: Company Strategy and Future Outlook - The acceptance of the NDA into the priority review process by the NMPA is expected to expedite the drug's market launch, with ongoing studies on both monotherapy and combination therapy for Tyrosine-9591 [5]. - The company emphasizes its commitment to addressing unmet clinical needs and continues to explore clinical research for combination therapies to better serve patients with lung cancer brain metastases [6]. - The submission of the NDA represents a significant milestone for the company, marking its entry into the commercialization phase and reflecting its dedication to innovative drug development in the oncology field [6][8].

Core Viewpoint - The company has received acceptance for the New Drug Application (NDA) of its investigational drug, TY-9591, by the National Medical Products Administration (NMPA) in China, indicating a significant step towards potential market approval for treating advanced non-small cell lung cancer (NSCLC) with specific genetic mutations [1][2]. Group 1: Drug Development and Clinical Trials - TY-9591 is a deuterated derivative of Osimertinib, demonstrating high bioavailability and effective brain penetration [1]. - The NDA application targets adult patients with locally advanced or metastatic NSCLC harboring EGFR exon 19 deletions (19DEL) or exon 21 (L858R) mutations, particularly those with CNS metastases [1]. - Phase I (TYKM1601101) and Phase II (TYKM1601201) clinical trial data indicate excellent intracranial and overall response rates in NSCLC patients with brain metastases, showcasing significant clinical benefits and addressing unmet medical needs [1]. - Key Phase II clinical trial data (TYKM1601202) further confirm superior efficacy compared to Osimertinib, particularly in terms of intracranial response rates and overall clinical benefits [1]. Group 2: Clinical Value and Advantages - TY-9591 exhibits enhanced clinical value and advantages over Osimertinib in terms of chemical structure, pharmacological action, clinical efficacy, safety, and resistance mechanism analysis [2]. - The drug is expected to significantly improve disease prognosis for patients with EGFR mutation lung cancer and brain metastases [2].

Core Viewpoint - The company has received acceptance from the National Medical Products Administration (NMPA) for the New Drug Application (NDA) of its investigational drug, TY-9591, which is a deuterated derivative of Osimertinib, targeting advanced or metastatic non-small cell lung cancer (NSCLC) patients with specific EGFR mutations [1][2] Group 1: Drug Development and Clinical Trials - TY-9591 is designed for first-line treatment of adult patients with locally advanced or metastatic NSCLC who have EGFR exon 19 deletions (19DEL) or exon 21 (L858R) mutations, along with CNS metastases [1] - Phase I (TYKM1601101) and Phase II (TYKM1601201) clinical trial data have shown excellent intracranial and overall response rates in NSCLC patients with brain metastases, indicating significant clinical benefits and addressing unmet medical needs [1] - Key Phase II clinical trial data (TYKM1601202) further confirms the superior efficacy of TY-9591 over Osimertinib in terms of intracranial response rates and clinical benefits [1] Group 2: Clinical Value and Advantages - As a deuterated compound of Osimertinib, TY-9591 demonstrates enhanced clinical value and advantages across various aspects, including chemical structure, pharmacological action, clinical efficacy, safety, and resistance mechanism analysis [2] - The drug shows a significant improvement in disease prognosis for patients, highlighting its potential impact on treatment outcomes [2]

Core Viewpoint - The company has received acceptance for the New Drug Application (NDA) of its investigational drug, TY-9591, by the National Medical Products Administration (NMPA) in China, indicating a significant step towards potential market approval for treating advanced non-small cell lung cancer (NSCLC) with specific mutations [1][2]. Group 1: Drug Development and Clinical Trials - TY-9591 is a deuterated derivative of Osimertinib, demonstrating high bioavailability and effective brain penetration [1]. - The NDA application targets adult patients with locally advanced or metastatic NSCLC harboring EGFR exon 19 deletions (19DEL) or exon 21 (L858R) mutations, particularly those with CNS metastases [1]. - Phase I (TYKM1601101) and Phase II (TYKM1601201) clinical trial data indicate excellent intracranial and overall response rates in NSCLC patients with brain metastases, fulfilling unmet clinical needs [1]. - Key Phase II clinical trial data (TYKM1601202) further confirm the superior efficacy of TY-9591 over Osimertinib in terms of intracranial response rates and clinical benefits [1]. Group 2: Clinical Value and Advantages - TY-9591 shows significant clinical value and advantages in terms of chemical structure, pharmacological action, clinical efficacy, safety, and resistance mechanism analysis [2]. - The drug is expected to improve disease prognosis significantly for patients with EGFR mutation lung cancer and brain metastases [2].